CN110799102A - Transcatheter atrial sealing skirt, anchor, tether, and method of implantation - Google Patents

Abstract

A medical assembly for implanting a cardiac sealing skirt into a heart at a cardiac sealing skirt deployment location, and related methods of implantation and delivery. An anchor is introduced intravascularly into the heart and implanted in the heart wall with an anchor delivery system and delivery cables. A second delivery system introduces a tether coupled to the implanted anchor and an atrial sealing skirt. The atrial sealing skirt includes an upper rim positioned to conform to the bottom of the atrium in the deployed position. The sealing skirt may be integrated with a valve or used as a container.

Description

Transcatheter atrial sealing skirt, anchor, tether, and method of implantation

technical field

The present invention generally relates to medical devices and systems for minimally invasive implantation of the heart, and methods of implantation of these devices and systems. More particularly, the present invention relates to medical devices and systems for minimally invasive implantation into any wall of the heart using one or more anchors that tether a catheter valve or other cardiac device within the heart. The present invention also relates to a transcatheter valve that seals at the atrial skirt with or without intracardiac leads to reduce paravalvular regurgitation.

Background technique

Transcatheter valves have been shown to be safe and effective replacements for native heart valves. These valves have been extensively tested to replace aortic, mitral, and pulmonary valves, but tricuspid valve replacement remains challenging given the complex and delicate anatomy that prostheses must attach to. Often it remains difficult to anchor transcatheter valves, especially transcatheter tricuspid valves, because doing so, either in situ position of the heart valve or in other body cavities, requires contact with the heart valve annulus or other The multiple shapes and sizes of body cavities interact. In this regard, the ability to tether a transcatheter valve to one or more anchors secured to the inner wall of the heart will provide greater safety for the prosthesis by reducing the need for fixation in the exact location of the prosthesis sex and flexibility. Especially useful for anchoring transcatheter tricuspid valve prostheses.

Intracardiac anchors and tethers have been described in several groups, but these systems have limitations in their application. For example Vidlund (1) and Lutter (2) describe a system for anchoring a prosthetic valve using a single tether that connects the distal end of the valve to an "epicardial tether fixation device" (Vidlund patent) which also Can be described as an anchor. Since the fixation device is located outside the apex of the heart (the epicardium), the system requires access to the apex of the heart through the chest wall. For patients with reduced pumping function (ejection fraction) or with fragile tissue, especially for applications involving the tricuspid valve, the need to access the heart through the chest may increase surgical risk.

In contrast, Rowe and colleagues (3) describe a tricuspid regurgitation coaptation device that uses an endovascular approach to fixate at the apex of the right ventricle without access to the heart through the chest wall. Rowe noted, "A flexible anchor rail is attached to the anchor, and an engagement element on a catheter sits on the anchor rail. Finally, a proximal anchoring feature subcutaneously secures the proximal end of the engagement catheter near the subclavian vein. ." The first limitation of this application is its inability to retrieve and reposition anchors in the wrong location or suboptimal configuration. Another limitation is securing the anchor track to the anchor. In contrast, it would be advantageous to be able to deploy the anchor first and then deliver various diameters of cable or tether or material locked in the anchor. By making the tether independent of the anchor, multiple arrangements of tether/anchor elements can be easily configured to maximize application customization to specific clinical needs. The last mentioned application describes a fixed connection between the anchor, the distal anchoring track, the engagement device and the proximal anchoring track, which requires that a large number of anchoring tracks remain in the superior vena cava and the innominate/subclavian vein. The proximal anchoring track is attached to a subcutaneous pocket, all of which present the risk of permanent venous leads, especially thrombosis, infection, and venous stenosis.

Solem and colleagues (4) overcome some of the limitations in their application by describing the possibility of a two-stage process whereby anchors can be configured first, then an "elongated body part" is attached to the anchor, and an elongated The main body portion is connected to the tether and the blood flow control device. "If the user wishes to replace the cover or other parts of the device, ... if ... the expandable valve portion is not the optimal size or distance from the anchor, a two-stage process can be very difficult it works". The anchors may consist of "arms or hooks that expand outward as the anchoring portion . . . is exposed." The elongated body can be attached to the anchor by a variety of mechanisms, including "snap or quick connect". In one embodiment, the elongate body may have a "ring structure...configured to advance around...a generally tubular protrusion of the anchor". To facilitate connection, "the proximal end of the anchor...includes a coupling member in the form of a generally tubular projection...with an outwardly extending locking clip...that can flex inwardly in response to inward pressure. But once Release the inward pressure and it will snap back outwards quickly."

Although the application of Solem has certain advantages, said application is also limited. The preferred method of delivering the anchor first is by advancing the anchor delivery catheter through the chest wall incision and then through a chamber in the heart into the incision. It would be even more desirable to be able to deliver the anchor by a true endovascular approach (eg, through the intrajugular or femoral vein) without the need for thoracic and cardiac chamber incisions. Next, the anchors consist of expandable arms or hooks that dig into the heart wall and then bend back, similar to a fishhook. Solem believes that the expandable hooks of the anchor can be retracted: "When the anchor portion... is pulled back into the distal sheath... from the distal sheath's... prongs Internal pressure...will cause the prongs of the anchor portion...to collapse inward...thereby collapsing the anchor portion...back to its delivered (ie pre-configured) state..." However in this way it can be easily Retrieving the back-curved prongs without damaging the tissue in the procedure is doubtful, and there is a need for a more secure retractable anchor. Also the fork may be safe in one location of the heart, but if it needs to be moved to another location it may cause injury (ie piercing) because the arm length is not adjustable. There is therefore a need for the ability to vary the tissue depth of the anchor (eg, the ventricular septum can tolerate greater depths compared to the ventricular free wall). Next, even via the step of separation, the connection of the elongated member to the anchor is secured such that the elongated member cannot rotate about the axis of the anchor. When adjusting a transcatheter valve on an elongated member, it may be necessary to rotate the valve to better seat within the native heart valve annulus, whereas Solem's elongated member cannot be rotated once secured to the anchor. Finally, the application of Solem requires the tether to be connected to the anchor through an elongated member. Being able to connect the tether directly to the anchor and have the ability to rotate the tether about the anchor's axis is particularly advantageous, as this will most closely mimic the function of the tendon chordae (the tether of the heart itself), which Attaches directly from the heart wall to the heart valve.

In addition, limiting paravalvular regurgitation of transcatheter mitral and tricuspid valves is challenging because mitral and tricuspid valves are complex saddle-shaped structures that are highly dynamic during the cardiac cycle of. A difficulty with tricuspid regurgitation is the frequent occurrence of intracardiac leads in patients with severe tricuspid regurgitation (TR). Because the ventricular lead traverses the annulus from the right atrium to the right ventricle, a transcatheter tricuspid valve must seal both the annulus and the lead to limit regurgitation in these patients.

In patients undergoing transcatheter aortic valve replacements (TAVR), researchers have developed techniques to mitigate paravalvular regurgitation, but these approaches have limitations, especially in the presence of intracardiac leads . In particular, balloon-expandable, mechanically-expandable, and self-expanding TAVRs incorporate sealing membrane material at the height of their stent frame annulus to reduce paravalvular regurgitation. The sealing membrane material consists of polyethylene terephthalate (called polyethylene terephthalate, PET or Dacron) or porcine pericardial tissue wrap. These sealing membranes work by filling the gap between the outside of the TAVR and the aortic annulus, but this requires apposition of the valve directly to the annulus. For transcatheter tricuspid valves, it may not be desirable or feasible to apposition the valve frame directly to the tricuspid annulus because, unlike the aortic annulus, the tricuspid annulus is expandable with minimal External support, and is prone to injury. Additionally, sealing the intracardiac lead by capturing it between the valve frame and the valve annulus increases the risk of lead injury, which is undesirable.

Most transcatheter mitral valve replacements (TMVR) have limited paravalvular insufficiency by capturing the base of the mitral valve leaflet between the valve frame and the valve annulus. Thus, like TAVR, TMVR's approach to mitigating paravalvular regurgitation may damage the fragile tricuspid annulus or trap it between the valve frame and annulus, thereby damaging the intracardiac lead. For example Medtronic Intrepid and NSCI Navigate valves are anchored by radial forces acting on the annulas (Intrepid) or by annular "winglets" or hooks (Navigate). The CardiAQ-Edwards TMVR interacts directly with the annulus using a sub-annular clamping mechanism, whereas the Neovasc Tiara valve interacts indirectly through fibrous trigones and also utilizes its own leaflet coaptation (both mechanisms can potentially trap and injure the wire) ). Three TMVR devices (Caisson, HighLife, and Mvalve) use a ring anchor as the docking system for the TMVR device, which can squeeze and possibly damage any intracardiac leads between the anchor and the TMVR device.

Damage to the intracardiac leads is not the only concern of the TMVR device for mitigating valve regurgitation. Because most TMVR devices reduce regurgitation by anchoring directly to the annulus to seal the mitral annulus, these devices limit the freedom of mitral annulus movement to varying degrees. Limiting this degree of freedom may lead to left ventricular dysfunction. For example, a study comparing transcatheter mitral valve repair (using Abbott Vascular's MitraClip device) with open heart surgery reported a significant reduction in mitral annulus motion in open heart surgery, the authors concluded that between open heart surgery and open heart surgery This was a factor in the reduction in left ventricular ejection fraction (LVEF) compared with transcatheter repair. Similarly, a study comparing flexible and rigid mitral annuloplasty rings reported significantly lower LVEF with rigid rings, which constrain mitral annulus motion more than flexible rings. Therefore, to limit valvular regurgitation, current TMVR devices must anchor and constrain the mitral valve annulus, which may have deleterious effects on left ventricular function.

To limit paravalvular regurgitation while avoiding confinement of the mitral annulus, the TMVR atrial skirt itself can alleviate paravalvular regurgitation and sealing around the intracardiac lead; e.g. the atria of Medtronic Intrepid, Neovasc Tiara, and Highlife TMVR devices The skirt reduces paravalvular regurgitation and aids in sealing around the wires within the heart. But if these TMVR devices were not using mitral annular anchoring, all of these skirts would have significant limitations. The NeovascTiara atrial skirt is most limited because it is asymmetrical to accommodate the "D-shaped" mitral annulus and aorto-mitral veil. This asymmetry is incompatible with the right atrial fundus and tricuspid annulus. The skirts of other TMVRs are symmetrical and may be compatible with the right atrial fundus and tricuspid annulus, but these skirts lack downward force and flexibility (along the vertical axis of the annulus), whereas downward force and flexibility are needed to reduce paravalvular regurgitation or seal intracardiac leads. Although Abbott VascularTendyne's valve avoids annular anchoring using an epicardial valve tether, its skirt still lacks the force and flexibility to seal the intracardiac lead. Like the skirts of other TMVR devices, the Tendyne valve skirt consists of flexible interconnecting wire rings covered with PET, and all of these skirts are funnel-shaped with a wide atrial top and a narrow valve annulus bottom. These funnel-shaped skirts are prone to inward flexing and do not have any mechanism to differentially increase the outward and downward forces of the atrial skirt. A mechanism to increase these forces, for example where the skirt interacts with the wire, would allow the skirt to control and restrain the wire. The aforementioned atrial skirt does not have such a mechanism. Thus a wire passing through the right atrium into the ventricle is not constrained by the top of the skirt; instead, the wire may bend the skirt inward to create a discontinuity in the skirt of the atrial floor, allowing paravalvular regression flow.

Finally another limitation of current atrial skirts is their fixation to their associated TMVR device. It would be advantageous to be able to separate the atrial skirt from the valve. That is, the ability to place the atrial skirt first and then deploy the transcatheter valve in the mitral or tricuspid space. Doing so will allow for a variety of combinations of atrial skirts and valves, which will maximize the ability to customize transcatheter valve placement and sealing based on anatomical variations in the atrium, annulus, and ventricle.

It is therefore highly desirable to manufacture a transcatheter valve skirt with several different features. First, its efficacy should be independent of the mitral or tricuspid annular anchors to avoid damaging annular anatomy or impairing ventricular function. Second, the skirt should be able to bend down with varying flexibility and force to accommodate the local topography of the atrial fundus and to accommodate and seal the intracardiac lead. Finally, it would be advantageous to develop an atrial skirt that could be placed either as an integral part of the transcatheter valve or independently of the transcatheter valve to facilitate the integration of pre-existing transcatheter valves. The valve is docked and sealed to the mitral or tricuspid annulus. Creating a skirt that can be placed independently and used as a docking system greatly expands the possibilities for treating patients with mitral or tricuspid valve disease.

Applicant's U.S. Patent Application No. 15/943,792 discloses a transcatheter anchor and tether implantation device, system and method, comprising: an anchor delivery system for introducing a tether connected to the anchor, and a valve delivery system for delivering, positioning and sealing the valve. According to the disclosure described below, an anchor delivery system includes an anchor that is implanted and not initially connected to a tether.

SUMMARY OF THE INVENTION

Minimally invasive implantable medical devices and systems are presented herein for implanting one or more anchors in the heart wall to connect tethers from the anchors to intracardiac devices, particularly transcatheter valves. Additionally, medical devices and systems are proposed that are implanted in a minimally invasive manner to seal transcatheter valves to reduce paravalvular regurgitation with or without intracardiac leads. In one aspect, using an anchor delivery catheter, the anchor is delivered entirely intravascularly without the need for a chest or heart incision.

In one aspect, the system includes an anchor sheath, an anchor delivery catheter, and an anchor screw attached to an anchor cap configured to receive a tether. The tether is configured to be attached to one or more tethers, and the tether is attached via the tether to the intracardiac device, such as a transcatheter valve or the like.

According to various aspects, the anchor screw may be an inclined plane wrapped around a spike-like head, or the anchor screw may be any helical device, such as an Archimedes-type screw, and may be "right-handed" or "left-handed". Anchor screws are composed of any metal alloy, such as, but not limited to, Nitinol, stainless steel, titanium, or cobalt-chromium.

The anchor cap is also composed of any metal alloy and is coupled to the proximal portion of the anchor screw. A proximal end of the anchor cap defines an internal "female" thread that receives the "male" thread of the distal end of the delivery cable. In one aspect, the delivery cable remains attached to the anchor cap during a process of securing the anchor cap to the heart wall, which occurs by rotating the anchor cap, thereby driving the anchor screw into the heart wall. In another aspect, after securing the anchor to the wall, a delivery cable is used to guide the tether until the docking loop of the tether is coupled with the anchor. The delivery cable can finally be unscrewed and removed from the anchor cap.

In one aspect, the tether has a docking loop attached to at least one docking loop arm, the docking loop arm defining an eyelet at a proximal end of the docking loop arm. Each eyelet is connected to the distal end of a tether rod that is connected to the eyelet by a hook. The tether rod is composed of any metal alloy, and the proximal end of the tether rod is connected to a cord. In one aspect, the butt loop of the tether is advanced over the anchor cap, thereby depressing the extended locking arm of the anchor cap. On the other hand, the docking ring reaches the end of the anchor cap, allowing the extended locking arms to push out, locking the docking ring and tether in place. On the other hand, even after locking in place, the tether is free to rotate about the longitudinal axis of the anchor cap without affecting the position of the anchor cap or anchor screw. For retrieval, the anchor delivery catheter is reversed on the locking arm, thereby depressing it and retracting the docking loop of the tether. According to one aspect, the atrial sealing skirt is integrated with the transcatheter valve and is delivered entirely intravascularly without the need to go through a thoracic or cardiac incision. Alternatively, the atrial sealing skirt is independent of the transcatheter valve valve and delivered entirely intravascularly without the need for a chest or heart incision. By placing the atrial skirt independently of the transcatheter valve, the atrial skirt is used as a docking system for any transcatheter valve.

In one aspect, whether or not the atrial skirt is integrated with the valve, the system includes an atrial sealing skirt configured to secure to the atrial floor, and at least one tether configured to couple the atrial sealing skirt to and and/or secured to any intracardiac wall by interaction of the tether with the anchor.

In one aspect, the atrial sealing skirt is self-expanding and consists of a nickel-titanium alloy and is covered with a synthetic material such as, but not limited to, polytetrafluoroethylene (PTFE) or polyethylene terephthalate ( polyethylene terephthalate, PET), or biofilm materials such as, but not limited to, bovine or porcine pericardial tissue.

In one aspect, the diameter of the membrane material covering the atrial skirt is larger than the valve annulus at the site of apposition such that, in use, the membrane material substantially covers the mitral or tricuspid valve annulus.

The frame of the atrial skirt starts out as a cylinder with the bottom of the cylinder at or below the height of the valve annulus and the top of the cylinder extending into the atrium. Extending from the top of the cylinder is an upper rim consisting of one or more wire extensions either laser cut or made of nitinol. These extensions are formed in the shape of, for example but not limited to, straight lines, arcs, hooks, circles, ellipses, sinusoids, or polygons with three or more sides. An extension of the upper edge (eg, the skirt body) is covered and/or joined by a synthetic or biofilm material. The superior edge is perpendicular to the atrial skirt body, or may be curved toward the atrial floor, such as a convex curve or a concave curve. In order to facilitate sealing when the superior edge bends towards the atrial fundus, the fabric covering is composed of braided or knitted fabrics that allow for "stretchability" to improve conformity to the topography of the atrial fundus ability and wraps all intracardiac wires.

In one aspect, one or more tubular bodies adjacent to the upper edge, extending longitudinally along the interior or exterior of the skirt body, are in the shape of a cylinder, the cross-section of which is any part of a circle, elliptical, parabolic or double A curved shape, or a polyhedron that takes the shape of a flat bottom and top, and is assumed to have three or more sides. These tubes are constructed of a membrane covering the skirt, or may be made of, but not limited to, stainless steel, nitinol, or other metal alloys. The one or more bodies are hollow and accommodate at least one tether connected to at least one tether, and each body is attached to a removable lock near the atrial surface of the skirt.

At least one anchor system includes an anchor screw configured to screw into or otherwise securely attach to any intracardiac wall. In one aspect, a tether is coupled to the anchor screw via the anchor cap, and at least one tether extends from the tether through at least one tubular body of the skirt body. The sealing skirt is thus connected to the cord through the tubular body, allowing the sealing skirt to interact independently or integrally with the valve to slidingly interact with the cord. In another aspect, the proximal end of the cord is attached to a suture that extends to the outside of the heart for use by the user.

The system also includes at least one atrial positioning rod, the proximal end of which is attached to the delivery system, and the distal end of which is reversibly coupled to a removable lock that is attached to the tube of the atrial skirt proximal end of the body. The positioning rod pushes or pulls the atrial skirt through the lumen of the positioning rod through sutures and/or tethers, thereby imparting differential force and flexion to the associated superior edge, thereby apposing the atrial floor and/or Conforms to the surrounding of the intracardiac lead. In another aspect, rotating the positioning rod and/or pushing or pulling the internal elements of the positioning rod causes the removable lock to engage the cord and/or suture, thereby securing the cord and/or suture to the atrium, maintaining force and / or the heart prevents the skirt from buckling to the atrial fundus intracardiac lead.

The related operation method is also provided. Other devices, methods, systems, features and advantages of medical devices and systems for minimally invasive implantation in the heart will be apparent to those skilled in the art from review of the following figures and detailed description. It is intended that all such additional devices, methods, systems, features and advantages be included within this specification within the scope of minimally invasive cardiac implantable medical devices and systems as claimed in the appended claims.

Description of drawings

Figure 1 is a cutaway perspective view of a heart showing a transcatheter atrial sealing skirt system positioned across the tricuspid valve of the heart.

Figure 2 is a cutaway perspective view of a heart showing a transcatheter atrial sealing skirt system positioned across the heart's mitral valve.

Figure 3 is a perspective view of a delivery cable of an anchor delivery device for anchoring a tether to a heart wall.

Figure 4 is a perspective view of an anchor for anchoring a tether to the heart wall.

Figure 5 is a perspective view of a tether used to anchor the atrial sealing skirt to the anchor.

6 is a perspective view of an anchor assembly consisting of a tether for connecting an atrial sealing skirt to an anchor, coupled with the anchor, for anchoring the tether to the heart wall.

7A-7C are perspective views of an anchor with a split anchor screw according to another aspect of the present invention.

8A is a side view of an anchor delivery device.

Figure 8B is a side view of the illustrated anchor delivery device within the delivery sheath.

Figure 8C is an end view of the anchor delivery device.

9A is a perspective view of an anchor delivery device positioned in the right ventricle.

9B is a perspective view of an anchor implanted in the inner wall of the heart.

10A and 10B show the delivery of the anchor removed.

11A is a perspective view of a tether delivery assembly on an implanted anchor.

11B and 11C are perspective views of the tether delivery assembly removed.

Figure 1 ID is an enlarged view of the fusion of the cord and suture.

12A is a perspective view of a sealing skirt delivery device with an atrial sealing skirt delivery system located in the right ventricle.

12B is a perspective view of an atrial sealing skirt delivery device with the delivery guide partially withdrawn and the sealing skirt deployed.

Figure 12C is an end view of the atrial sealing skirt.

Figure 13A is a perspective view of the positioning of the atrial sealing skirt on the right atrium floor by the atrial positioning rod.

13B is a perspective view of the final position of locking the atrial sealing skirt in the tricuspid annulus by the atrial lock, with the positioning rod partially withdrawn;

14A and 14B are side and top perspective views of an atrial sealing skirt.

Figure 15A is a cutaway perspective view of the heart showing the atrial sealing skirt in place.

Figure 15B is a cutaway perspective view of the heart showing the atrial sealing skirt placed on and conforming to the atrial floor.

Figure 16A is a cutaway perspective view of the heart showing the atrial sealing skirt conforming to the atrial floor and sealing around the intracardiac lead.

Figure 16B is an enlarged perspective view of the atrial skirt conforming to and sealing around the intracardiac lead.

17A is an enlarged side view of the atrial sealing skirt coupled to the atrial locating rod and tether.

Figure 17B is an enlarged side view of the locking system.

Figure 18A is a perspective view of the locking system.

Figure 18B is a perspective cutaway view of the locking system.

19A is a cross-sectional side view of a locking system for locking an atrial sealing skirt in an unlocked position.

19B is a cross-sectional side view of a locking system for positioning the atrial sealing skirt in a locked position.

20A is a partial cross-sectional view of the locking system in a locked position.

Figure 20B is a perspective view of the locking system.

Figure 21A is a cross-sectional view of a heart with the atrial skirt within the heart and all delivery devices removed.

Figure 21B is a cutaway view of the heart with the atrial skirt located within the heart and showing the suture cutter.

Figure 22 is a side view of the sealing skirt with one edge transitioning from concave to convex.

23A and 23B are perspective and top views of a ventricular sealing skirt with a valve comprised of valve leaflets integrated into the skirt.

24A and 24B are perspective and top views of an atrial sealing skirt for receiving a valve.

25A-25F are perspective views of an anchor having an anchor screw and an anchor cap configured to receive a connecting ring and tether system, shown in sequential steps.

Detailed ways

The present invention may be understood more readily by reference to the following detailed description, examples and claims, as well as the preceding and following descriptions thereof. Before the present system, apparatus and/or method is disclosed and described, it is to be understood that this invention is not limited to the particular system, apparatus and/or method disclosed, as such may, of course, vary unless otherwise indicated. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting.

The following description of the invention is provided as a workable teaching of the best presently known aspects of the invention. Those skilled in the relevant art will recognize that many changes can be made in the aspects described while still obtaining the beneficial results of the present invention. It will also be apparent that some of the desired benefits of the present invention can be obtained by selecting some of the features of the present invention without utilizing other features. Accordingly, those skilled in the art will recognize that many modifications and variations to the present invention are possible, and in some cases may even be desirable, and are a part of the present invention. The following description is therefore provided by way of illustration of the principles of the invention, not limitation thereof.

As used herein, the singular forms "a (a, an)" and "the (the)" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a tether" includes versions having two or more tethers unless the context clearly dictates otherwise.

Ranges herein can be expressed as from "about" one particular value and/or to "about" another particular value. When such a range is expressed, on the other hand, from one particular value and/or to another particular value is included. Similarly, when values are expressed as approximations, the antecedent "about" is used, it will be understood that the particular value forms another version. It will be further understood that an endpoint of each range is significant relative to and independent of the other endpoint.

As used herein, the terms "optional" or "optionally" mean that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not. Happening. As used herein, "fluid" refers to any substance that flows freely, including liquids, gases, and plasma. As used herein, "fluid communication" refers to any connection or relative positioning that allows free flow of substances between associated components.

The present application relates to a number of medical devices and systems that are minimally invasively implanted in the heart, and methods of implanting these devices and systems. More particularly, the present application relates to devices, methods, and systems for the intravascular introduction and anchoring of an anchor 75 to the heart wall, and the valve 100 (see Figure 23 and Figures 14A and 14B ). ) is implanted in the heart, which is tied to the anchors 75 in place of the native valve. And a tether assembly cooperates with the anchor 75 which connects the valve 100 to the anchor 75 . In addition, the valve 100 includes a sealing skirt 46 for cooperating with the valve 100 to conform to the corresponding atrial fundus to prevent paravalvular regurgitation of prosthesis of the prosthesis. Applicant's US Patent Application No. 15/943,792 relates to an atrial sealing skirt and anchor that are tied to each other and implanted integrally. According to the disclosure herein, the anchor is implanted independently of the tether and the atrial sealing skirt. It should be understood, however, that various components of the present application and Applicants' previously filed disclosure are interchangeable. Anchors such as Applicants' previously disclosed anchors may be implanted without a coupled tether during delivery of the anchor. Rather, the tether system described herein may also be used in conjunction with the plurality of anchors disclosed therein.

Anchor Components:

The assembly of anchor assembly 101 shown in FIGS. 3-6 includes an anchor 75 having an anchor screw 17 , an anchor cap 16 and a delivery cable 12 allowing a tether 18 to be delivered. The delivery cable 12 is removably connected to the anchor cap 16 . As shown, the anchor screw 17 is sized and configured to be a helical screw for securing to the inner wall of the heart. But optionally the anchor screw 17 can be sized differently (longer or shorter depending on the length of the heart wall to which it is attached), and can be configured as an inclined plane, a spike-like head, or as known to those skilled in the art any other type of screw. In one aspect, the screw is composed of any known metal alloy including, but not limited to, nitinol, titanium, or cobalt-chromium. In another aspect, the metal alloy of screw 17 may be coated with biological tissue, such as the pericardium of bovine, sheep, porcine or equine, or any combination of anti-inflammatory drugs that may promote healing and limit inflammation. The tip 76 of the anchor screw 17 is optionally constructed and/or coated from the same or a different material as the anchor screw 17, and can be made with a blunt or sharp tip.

In use, anchor 75 is secured to the heart wall by rotating anchor screw 17 until tip 76 is at the desired depth in the heart wall. The depth to which the anchor screw 17 is screwed can be adjusted according to the position within the heart. For example, anchor screws 17 can be implanted deeper into the interventricular septim for greater fixation, as opposed to the free wall of the ventricle, the epicardial wall, where the shallower implant is Safer. By reversing the rotation of the anchor screw 17, the anchor 75 is safely removed from the heart wall, either repositioned, or completely removed.

The anchor cap 16 includes at least one locking arm 78 extending radially outward from the anchor cap 16 . The locking arms 78 are sized and configured to releasably secure a portion of the tether 18 (described below) to the anchor cap 16 . At least one locking arm 78 moves between a first locked position in which the locking member 78 extends a first distance away from the body of the anchor cap 16 and a second unlocked position in which the locking member 78 extends away from the body of the anchor cap 16 The anchoring cap 16 extends a second distance that is less than the first distance. The anchor cap 16 includes at least one biasing member (not shown), such as a spring, configured to urge each locking arm 78 toward the first locking position. As shown, a plurality of locking arms 78 are provided that are equally spaced around the circumference of anchor cap 16, although it is contemplated that locking arms 78 need not be equally spaced.

Referring now to FIG. 3 , delivery cable 12 includes flexible delivery wire 13 having a distal threaded end 14 located or formed on the distal end of delivery wire 13 . The delivery wire is constructed of, but not limited to, stainless steel, nitinol, or other metal alloys, with or without a hydrophilic coating, or with or without a polymer coating, such as polytetrafluoroethylene (PTFE) . The distal threaded end 14 is sized and configured to selectively engage a complementary thread formed in a cavity in the proximal end 77 of the anchor cap 16 . See Figures 4 and 6. In use, the distal threaded end 14 is advanced (eg, screwed) into the proximal end 77 of the anchor cap 16 to connect the anchor cap 16 to the distal end of the flexible wire 13 . As described more fully below, the distal threaded end 14 is unscrewed from the proximal end of the screw.

According to another aspect of the present invention, an expanded anchor assembly 102 is shown in FIGS. 7A-7C. As shown, the anchor assembly 102 is an interventricular anchor, eg, across the interventricular septum. Anchor assembly 102 includes anchor cap 16 and locking arm 78 for mating with tether 18 as described above. The anchor assembly 102 also includes an anchor shaft 105 having a distal tip 107 configured to penetrate the inner wall of the heart. The anchor shaft 105 and the anchor screw 17 are composed of at least two (three as shown) shafts and the anchor area 108 . The anchoring region 108 is held during implantation and intracardiac penetration by an internal tensioning device (eg, tensioning wire 109 ) divided into at least two or shown as three lines 109 terminating at each anchoring region 108 of the distal tip 107. Once the distal tip 107 of the anchor shaft 105 enters the intracardiac wall (eg, the ventricular septum), the internal tension wires 109 are released and relaxed, allowing the plurality of shaft regions 108 to separate by the action of an internal biasing member (not shown), the internal Biasing members, such as, but not limited to, one or more springs, are positioned along one or more inner walls of the shaft region 108 .

According to another aspect of the present invention, as shown in FIGS. 25A-25F, an anchor assembly 103 is shown. The anchor 103 includes an anchor shaft 112 and an anchor screw 114 . As shown, the anchor screw 114 has a helical configuration and extends distally from the anchor screw base 115 . Anchor screw base 115 defines a portion of at least one or more (as shown) anchor flanges 116, and a recessed area 117 therebetween. The anchor shaft 112 includes at least one or more locking members 118 (shown in FIG. 25B ). The locking member 118 is biased radially outward from the anchor shaft 112, eg, by a spring (not shown). An anchor connector 120 and connector rod 121 cooperate with the anchor shaft 112 to rotate the anchor screw 114 . The anchor connector 120 defines at least one or more (as shown) holes 122 configured to receive the anchor flange 116 . Accordingly, the anchor connector 120 and the connector rod 121 are matingly connected with the anchor shaft 112, thereby urging the locking member 118 inward. The cooperation of the hole 122 and the flange 116 integrates the anchor connector 112 and the anchor screw base 115 . Rotation of the connector rod 121 thereby rotates the anchor screw 114 for intraventricular or epicardial implantation to the inner wall of the heart.

After the anchor screw 114 is implanted, a tether loop 125 is applied over the connector stem 121 and the anchor connector 120 and abuts the proximal end of the anchor screw 114 . The tether loop 125 includes a generally cylindrical first distal portion 126 and a second proximal portion 127 having a larger diameter than the first portion 126 . The second portion 127 defines at least one or more (as shown) apertures 129 configured to receive the tether rod 130, as shown in Figures 25E and 25F. As shown in Figure 25D, the anchor connector 120 and the connector rod 121 are removed. The plurality of locking members 18 are urged radially outward to engage the second portion 127 of the tether loop 125 to lock the tether loop 125 to the anchor screw base 115 . The tether rod 130 operates as described above to cooperate with the atrial sealing skirt 46 .

Tether Components:

When the flexible wire 13 is coupled to the anchor 75 , the flexible wire acts as a guide rail, advancing the tether 18 to the anchor 75 . Tether 18 includes one or more tether rods 19 rotatably connected to docking ring 20 . As shown in FIG. 5 , the tether rod 19 is connected to the eyelet 70 defined by the docking ring arm 71 . The tether 18 is advanced over the flexible wire 13 of the delivery cable 12 and the docking loop 20 of the tether 18 presses the at least one locking arm 78 of the anchor cap 16 to the second unlocked position. With the locking arm 78 in the second position, the tether 18 passes over the locking arm 78 on the anchor cap 16 until the docking ring 20 abuts against and/or is adjacent the distal end 79 of the anchor cap 16 . The biasing member of the anchor cap 16 urges the at least one locking arm 78 to the first locking position, thereby releasably coupling the docking ring 20 and the remainder of the tether 18 to the anchor 75 .

In one aspect, when the tether 18 is coupled to the anchor 75, it rotates a full 360 degrees about the longitudinal axis of the anchor. Alternatively, in another aspect, the tether 18 may be constrained to a smaller angle of rotation by the interaction of a portion of the tether 18 with the at least one locking arm 78 .

As shown in FIG. 6 , in one aspect, the tether 18 includes at least one docking loop arm 71 coupled to the docking loop 20 , and at least one tether rod 19 coupled to the docking loop arm 71 . The distal ends of the docking ring arms 71 are securely coupled to or integrally formed with the docking ring 20 . As shown, at least one docking ring arm includes a plurality of docking ring arms 71 . As shown, the plurality of docking ring arms 78 are equally spaced around the circumference of the docking ring, although it is contemplated that the docking ring arms 71 need not be equally spaced. The docking ring arm 71 defines an eyelet 70 . The tether rod 19 includes a tether rod hook 72 configured to cooperate with the eyelet 70 .

A proximal end of each docking loop arm 71 is rotatably coupled to the distal end of the corresponding tether rod 19 . As shown, the tether rod hooks 72 are defined by the tether rods 19 and are coupled to or integrally formed with the distal end of each tether rod 19 . In another aspect, eyelet 70 and tether bar hook 72 are sized and configured such that tether bar hook 72 is inserted into eyelet 70 to securely, rotatably couple tether bar 19 to docking ring 20 . In use, each tether bar hook 72 rotates about the circumference of the eyelet 70 . As shown in Figure 5, the proximal end of each tether rod is connected to a tether 21. Tether rod 19 and tether rod hook 72 may be constructed of any metal alloy.

Tether 18 is configured to cooperate with any intracardiac anchor including, but not limited to, the interventricular and epicardial anchors disclosed herein, as well as those previously disclosed by Applicants incorporated herein by reference. Intraventricular and extracardiac anchors.

Anchor Delivery Device:

Referring now to FIGS. 8A-8C and 9A-9B, the anchor delivery device 23 for positioning and deploying the anchor cap 16 in the desired position is shown, and is similar to that of the anchor assembly 101 shown in FIGS. 3-6. component related. Anchor assembly 102 is shown in FIGS. 7A-7C . Delivery device 23 includes an anchor delivery guide 25 and an anchor delivery rod 29 . The anchor delivery guide has a distal end 28 and an inner guide lumen sized and configured such that at least a portion of the anchor delivery rod 29 extends therethrough. At least a portion of the anchor delivery guide 25 is flexible such that the distal end 28 of the anchor delivery guide 25 is positioned at or near the intracardiac wall 7 .

Anchor delivery rod 29 is configured to securely attach anchor screw 17 to intracardiac wall 7 . Anchor delivery rod 29 has a distal end 31, an opposing proximal rotational handle 30, and an inner rod lumen extending therebetween. The inner rod lumen is sized and configured so that at least a portion of the delivery cable 12 extends therethrough. At least a portion of the anchor delivery rod 29 is flexible such that a rod tip 31 at the distal end of the anchor delivery rod 29 can be positioned at or near the intracardiac wall 7 .

A portion of the anchor cap 16 (as shown near the distal end 79 of the anchor cap) is received by the anchor rod tip 31 and extends therein. The outer configuration of the proximal portion of the anchor cap 16 includes a first surface configuration, and the inner wall configuration of the distal portion of the anchor rod 29 has a second configuration, wherein the first configuration and the second configuration cooperate with each other. Rotation of the anchor delivery rod 29 thus rotates the anchor cap 16 when the anchor cap 16 is positioned in and engaged with the anchor rod tip 31 . In this position, the anchor screw 17 extends distally from the anchor delivery rod 29, and the delivery cable 12 extends through the inner rod lumen of the anchor delivery rod 29 as shown in FIG. 8B.

The anchor delivery device 23 also includes a guide handle 26 having a deflection knob 27 coupled to the anchor delivery guide 25 . Guide handle 26 and deflection knob 27 are configured and used to help guide distal end 28 of anchor delivery guide 25 to intracardiac wall 7 . A rod handle 30 is coupled to the anchor delivery rod 29, wherein rotation of the rod handle rotates the rod tip 31 and the anchor cap 16 when the anchor cap is positioned in the anchor rod tip 31 .

As shown in FIG. 8A , sheath 24 is configured to receive anchor delivery guide 25 . The sheath 24 is in fluid communication with the anchor delivery guide such that a fluid, such as heparinized saline, passes through the sheath 24 around the anchor delivery guide. A central sheath channel 33 (FIG. 9B) is defined in sheath 24 for providing means in communication with the inner guide lumen of anchor delivery guide 25 for anchor delivery rod 29 and other system components to pass through. Extends through the central jacket channel 33 .

Methods of implanting anchors:

As shown in FIG. 9A , in the tricuspid annulus, for example, a J-shaped wire 34 is guided intravascularly by the user to the inner wall 7 of the heart. The anchor delivery device 23 is then guided over the J-line until the distal end 28 of the anchor delivery guide 25 is at or near the intracardiac wall 7 . Figures 9-11 show the anchoring assembly 10 of Figures 3-6 implanted into an intracardiac wall, ie, the epicardial wall. Anchor assembly 101 may also be implanted in an interventricular wall. J-shaped wires such as, but not limited to, 0.025" or 0.035" J-shaped wires. J-shaped wires with other diameters are of course contemplated. Anchor cap 16 is coupled to distal end 31 of anchor delivery rod 29 . The anchor delivery rod 29 is then inserted through the inner guide lumen of the anchor delivery guide 25 until the anchor cap 16 and the distally extending anchor screw 17 are located at or near the intracardiac wall 7 .

The anchor assembly 102 of Figures 7A-7C may also be implanted and guided by the J-shaped wire 34, eg, into the intraventricular wall, such as the intraventricular wall 7 shown. The anchor assembly 103 of Figures 25A-25F may also be implanted and guided into the intracardiac wall 7 by the J-shaped wire 34, eg, the intraventricular or epicardial wall.

When the anchoring screw 17 of the anchor system 101, 102 or 103 is positioned adjacent the intracardiac wall 7, the rotary handle 30 of the anchor delivery rod 29 or 121 is rotated to cause a corresponding rotation of the anchoring cap 16, as shown in Figure 9B. For example, the rotary handle 30 is rotated in a first direction to cause corresponding rotation of the anchor cap 16 . Anchoring screw 17 coupled to anchoring cap 16 is also rotated and threaded into a portion of the inner wall of the heart until anchoring cap 16 is adjacent the apex wall. It should be noted that the anchoring screw 17 may or may not extend completely through any intracardiac wall, but does not require transapex access. When the anchor cap 16 is placed in the desired position, the anchor delivery rod 29 and anchor delivery guide 25 are retracted from the heart 2, as shown in Figure 10A. As shown in FIG. 10B , after placement of the anchor cap 16 , the flexible wire 13 of the delivery cable 12 extends from the anchor cap 16 through the tricuspid annulus and through the right atrium 3 .

Atrial sealing skirt:

As shown in FIGS. 14A, 14B, 23A, 23B, 24A, and 24B, the system 1 includes a heart valve 100 having an atrial sealing skirt 46 with an upper skirt edge 47 circumferentially along the upper end of the valve 100. extend. Atrial sealing skirt 46 includes a substantially cylindrical atrial skirt body 48 and said atrial skirt upper edge 47 configured to conform to an atrial floor 4, such as the right atrial floor as shown. Atrial sealing skirt 46 is coupled to anchor 75 by tether 18 as described herein. The tether 21 , which is fused or otherwise coupled to the tether rod 19 of the tether 18 , connects the valve 100 to the anchor 75 when the anchor 75 is secured to the inner cardiac wall 7 .

The transcatheter atrial sealing skirt 46 is shown in FIG. 1 and is sized and configured to fit a tricuspid valve (in the example shown) that sits between the right atrium 3 and the right ventricle 6 . The sealing skirt 46 may be pre-assembled with the valve leaflets 110 as an integrated valve 100 (FIGS. 23A, 23B), or the sealing skirt 46 may be constructed without valve leaflets and used as a docking system, for a separate transcatheter valve (Fig. 24A, Fig. 24B). This is by way of example. But alternatively, as shown in FIG. 2 , the valve may be of slightly different size and configuration and may be positioned in the mitral annulus between the left atrium 8 and the left ventricle 11 . As such, these devices, systems, and methods vary slightly and can be used on the tricuspid or mitral valve, and can be placed intravascularly through venous structures including, but not limited to, the internal jugular, subclavian, subclavian, or femoral veins .

Atrial sealing skirt 46 is self-expanding (ie the skirt is compressible so that it fits through the catheter of System 1) and is composed of Nitinol, but may also include, but is not limited to, stainless steel, Nitinol or components made of other metal alloys. In another aspect, the lower diameter of the atrial sealing skirt is less than or approximately equal to deployment location 5 (tricuspid annulus) or deployment location 10 (mitral annulus), thereby preventing or reducing apposition to the fragile tricuspid annulus (apposition), and prevent or reduce confinement of the mitral annulus.

As shown in FIGS. 12C , 14A and 14B, 23A and 23B, and 24A and 24B, at least one tubular body 53 is defined in the outer wall of the atrial sealing skirt 46. Each tube is sized and shaped such that a portion of cord 21 (as shown in FIGS. 12A and 12B , connected at the proximal end to suture 45 ) extends through tube 53 to connect tether 18 to atrial sealing skirt 46 , allowing free movement until skirt 46 is locked in place. In another aspect, the atrial sealing skirt 46 has anchoring elements (not shown) positioned along its outer diameter. These anchoring elements allow for fixation to the tricuspid or mitral valve annulus and/or leaflets, but do not necessarily use the primary fixation mechanism.

At least one tether 21 is coupled to tether rod 19 of tether 18 and a proximal portion of tether 21 is coupled to suture 45 . In one aspect, the rope may be a strong and flexible rope such as, but not limited to, expanded polytetrafluoroethylene (ePTFE) or high-molecular-weight polyethylene (UHMW) rope. In use, as will be described more fully below, the central portion of cord 21 (between the distal and proximal ends) extends through and/or is coupled to atrial sealing skirt 46 to attach the skirt to the tricuspid The annulus or mitral annulus remains in the desired position.

23A and 23B also show the ventricle sealing skirt 46 . The sealing skirt 46 is a unitary valve 100 consisting of leaflets 110 extending radially inward from the sealing skirt body 48 . The leaflets 110 consist of bovine, equine or porcine pericardial leaflets. Atrial sealing skirt 46 may be used as a docking system for any conventional valve, or may be pre-assembled to include valve 100 consisting of leaflets 110 . If the atrial sealing skirt 46 contains a valve 100 consisting of a plurality of leaflets 110 sewn to the interior of the sealing skirt body 48, this configuration will function as any conventional valve, where the leaflets 110 are sewn to the interior of the sealing skirt body 48. Opens during diastole (relaxation of the heart), allowing blood to pass from right atrium 3 into right ventricle 6, or from left atrium 8 into left ventricle 11, and closes during systole (systole, contraction of the heart), thereby Prevents backflow of blood from the right or left ventricle to the right or left atrium, respectively.

As shown in FIGS. 14A and 14B, 23A and 23B, and 24A and 24B, the atrial sealing skirt 46, defined by the atrial skirt body 48 and the atrial skirt superior edge 47, includes a membrane-like material, said and The diameter of the sealing skirt 46 is larger than the annulus of the deployment location. For example, the skirt diameter of the atrial sealing skirt 46 may be larger than the diameter of the tricuspid or mitral valve annulus. In another aspect, the atrial skirt is formed of, but is not limited to, a synthetic material selected from the group consisting of polycarbonate, polyurethane, polyester, expanded polytetrafluoroethylene (ePTFE), poly Ethylene terephthalate (PET), silicone, natural or synthetic rubber, or a combination thereof. The atrial skirt 46 may also be covered with adult or juvenile bovine, ovine, equine or porcine pericardium. Alternatively, at least a portion of the atrial sealing skirt 46 may be formed from alternative materials such as, but not limited to, polyurethane foam or other polymers.

In another aspect, at least a portion of the atrial sealing skirt 46 has one or more fixation members (not shown) along its length to allow further anchoring to the right atrial floor and/or other portions of the atrial side of the tricuspid annulus , preventing the atrial sealing skirt 46 from migrating into the proximal right atrium 3, thereby preventing prosthesis instability (eg, rocking) and paravalvular regurgitation. Optionally, with minor modifications, these fixation members allow for further anchoring of the atrial sealing skirt 46 to the left atrial floor and/or portions of the atrial side of the mitral annulus, thereby preventing migration of the atrial sealing skirt 46 to the proximal The left atrium 8, also prevents instability (eg rocking) of the prosthesis and paravalvular regurgitation.

The atrial sealing skirt 46 includes at least an atrial skirt body 48 and an atrial skirt upper edge 47 . As shown, the atrial skirt body 48 is cylindrical and has variable lengths and diameters. It is optionally composed of laser cut or molded Nitinol, but may also contain any other metal alloying elements, and may be covered with the above-described biofilm materials or synthetic materials along any portion of its circumference or length. As shown, the upper rim 47 extends radially outward and downward from the skirt body 48 to form a generally concave upper rim with a depression facing either the right atrial floor 4 or the left atrial floor 10 . The rim 47 extends circumferentially around the upper end of the skirt body 48 .

At least one or a plurality of flexible extension members 49 are provided, and may include, for example, but are not limited to, laser cut or molded nitinol. Attached to the top of the skirt body by extension member base 50 and terminating at extension member tip 51 . An elastic sealing membrane 52 extends between one or more extension members 49 perpendicular to adjacent extension members 49 . In Figures 14A and 14B, the extension members 49 may extend radially outward and substantially linearly, but this is exemplary. As shown in Figures 23A, 23B, 24A, and 24B, the extension member may be non-linear and generally U-shaped. As shown, the sealing membrane 52 extends circumferentially around the skirt edge 47 . It can also extend only a part of the circumference. The seal skirt body 48 includes a plurality of supports 114, which are similar to the extension members 49 of the upper edge 47, such as, but not limited to, laser cut or molded nitinol. As shown, the supports 114 form a lattice-like configuration, although other configurations are contemplated, including but not limited to vertically extending supports.

As described above, the sealing member 52 is composed of biological tissue or synthetic fibers. On the one hand, synthetic fabrics are braided or knit, allowing the "stretchability" required to conform to the shape of the atrial fundus, including the ability to cover and seal intracardiac leads, such as pacemaker leads ) 66, as shown in Figures 16A and 16B. As shown in FIG. 16A , according to one aspect, the atrial skirt superior edge 47 conforms to the right atrial floor 4 and seals around the intracardiac lead 66 . In Figure 16B, extension member 49 is attached to atrial skirt body 48 via extension member base 50, and extension member tip 51 is bent downward, allowing elastic sealing membrane 52 to wrap around the top of intracardiac lead 66, preventing the lead Reflux around. This configuration requires a downward force applied by one or more atrial locating rods 44 attached to one or more tubes 53 and by one or more removable locking members 56 (FIG. 17B) is locked in place, the removable lock 56 being integrated inside the atrial end of the tube 53 as described herein.

Tether and Atrial Sealing Skirt Delivery Components:

According to the method described above, the anchor 75 is introduced and secured to the intracardiac wall by the anchor delivery device 23, and the anchor 75 including the anchor screw 17 has been implanted in the intracardiac wall. Anchor cap 16 and delivery cable 13 remain within the heart and are ready to receive tether 18 as described above.

Referring now to FIGS. 11A , 11B, 11C, and 11D, and as described above, tether 18 is passed over the flexible wire 13 of delivery cable 12 through the delivery system of the atrial skirt in the form of sheath 137 as shown go ahead. The tether 18 is locked to the anchor cap 16 by coupling the butt ring 20 to the anchor cap 16 . At least one cord 21 extending from tether rod 19 is coupled to at least one tether rod 19 . At least one tether 21 is proximally connected to at least one suture 45 that extends extracorporeally through the central lumen 33 of the delivery sheath 137 . Once the tether is locked to the anchor cap 16, the sheath 137 is retracted as shown in Figure 11C, allowing the implanted anchor 16, tether 18, cord 21 and suture to extend from the implantation site. In the aspect shown in FIG. 11C, a tethered delivery sheath 137 is provided as a second delivery guide and differs from the atrial sealing skirt delivery guide sheath 38, which Sheath 38 is a third delivery guide, as described below. The tether sheath 137 is thus removed, and the delivery guide sheath 38 of the atrial sealing skirt is used. This can however be achieved in a single step, as shown in Figures 12A-12B, where the same sheath 38 delivers the tether 18 and the atrial sealing skirt 46 with the same sheath and constitutes a second delivery step.

Referring now to FIGS. 12A and 12B , the delivery system 37 for positioning and deploying the atrial sealing skirt 46 at the desired deployment position 5 or 10 is shown. Atrial sealing skirt delivery system 37 includes atrial sealing skirt delivery guide 38 , nose cone 43 , atrial sealing skirt deployment knob 39 and at least one atrial positioning rod 44 . The atrial sealing skirt delivery guide 38 has a distal end 41, an opposing proximal atrial sealing skirt deployment knob 39, and an inner guide lumen 40 extending therebetween. The inner guide lumen 40 is sized and configured so that an atrial sealing skirt 46 and other system components can be selectively and removably inserted therein. At least a portion of the delivery guide 38 of the atrial sealing skirt is flexible so that the distal end 41 of the anchor delivery guide 25 passes over the deployment location 5 and into the right ventricle 6 . Alternatively, the distal tip 41 is positioned beyond the deployment location 10 and into the left ventricle 11 .

The deployment knob 39 of the atrial sealing skirt is connected to the proximal end of the delivery guide 38 of the atrial sealing skirt. The configuration knob of the atrial sealing skirt defines a central channel 60 in fluid communication with the inner guide lumen 40 . The atrial positioning rod 44 , guide wire 13 and/or at least one suture 45 can thus extend through the central passage 60 into the inner guide lumen 40 . As shown, the configuration knob 39 of the atrial sealing skirt can be rotated and configured such that rotation of the knob 39 in a first direction causes the distal tip 41 of the delivery guide 38 of the atrial sealing skirt to disengage adjacent the atrial sealing skirt 46 . is retracted, thereby expanding the atrial sealing skirt 46 . The nose cone 43 , which may be any conventional nose cone, is connected to the delivery guide 38 of the atrial sealing skirt and is configured to guide the atrial sealing skirt 46 to the deployment position 5 .

Locking System:

13A and 13B, at least one atrial locating rod 44 has a distal end 54, a proximal end 61 and an inner rod lumen 62 extending therebetween, the inner rod lumen being sized and configured such that the part inserted into it. At least a portion of the atrial positioning rod 44 is flexible such that the distal end 54 of the atrial positioning rod can be positioned at or near the deployment position 5 .

At least one positioning rod 44 is connected to the pipe body 53 . As shown in FIGS. 13A and 13B , each tube body 53 includes a removable locking member 56 ( FIGS. 17A and 17B ) configured to securely attach at least one cord 21 . Said cord 21 is thus firmly attached to the tether rod 19 of the tether 18, which is coupled to the anchoring cap 16, is fixed to the intracardiac wall 7 by means of the anchoring screw 17, and for example the removable locking piece 56 securely locks the A cord 21 is attached in the right atrium.

17A, 17B, 18A, 18B, 19A and 19B, the locking system 55 includes a detachable locking member 56, integrated in the tube body 53, attached to the first gate hypotube 57 and the second gate hypotube 57 Two retract the hypotube 58. Inside the removable lock 56 is a locking clip 59 . Referring now to Figure 21B, the system 1 also includes a suture cutter 65 sized and configured to pass through the delivery sheath 24 to cut at least one suture 45 (shown in Figure 21B).

Methods of implanting, positioning and locking the atrial skirt:

In use, the system 1 implants the atrial sealing skirt 46 (with an integrated valve) using a transcatheter approach by placing the right or left ventricular anchor 75 and docking the tether 18 to the anchor 75 . As shown in FIG. 12A , the delivery system 37 of the atrial sealing skirt is placed over the flexible wire 13 of the delivery cable 12 and inserted into a portion of the heart 2 . At least a portion of the suture 45 is passed through the wall of the atrial sealing skirt 46 when the atrial sealing skirt delivery guide 38 with the atrial sealing skirt 46 and integrated valve 100 preassembled to the distal end 41 thereof are inserted into the heart In the defined at least one tube 53, as shown in Figures 12B and 12C, and with the advancement of the delivery guide 38 of the atrial sealing skirt, the suture 45 and at least a portion of the cord 21 extend proximally along and proximally. , beyond the inner guide lumen 40 of the delivery guide 38 of the atrial sealing skirt. A portion of at least one cord 21 thus extends through and beyond the distal end 41 of the delivery guide 38 of the atrial sealing skirt, and a portion of at least one suture 45 extends through and beyond the delivery guide 38 of the atrial sealing skirt. The atrial sealing skirt delivery guide 38 is positioned so that the atrial sealing skirt delivery guide 38 with the atrial sealing skirt 46 and integrated valve 100 pre-installed to its distal end 41 pass through deployment position 5 and into the right ventricle 6 .

The atrial sealing skirt 46 and valve 100 are pre-installed into the distal end 41 of the delivery guide 38 of the atrial sealing skirt to be positioned in the deployment position 5 . As shown, sutures 45 are pre-bonded with valve 100 such that each suture 45 is passed through at least one tube 53 defined by the wall of atrial sealing skirt 46, as shown in Figures 12B and 12C. As the atrial sealing skirt 46 and the distal end 41 of the delivery guide 38 of the atrial sealing skirt are advanced as a unit and approach the deployment position, the end of the suture 45 and a portion of the cord 21 will become threaded through the atrial sealing skirt Tube 53 as defined in 46. In this way, the atrial sealing skirt 46 can be moved along the length of at least one cord until the desired deployment position 5 is reached. That is, the atrial sealing skirt floats freely on the cord 21 until locked by the removable lock 56 .

The deployment knob 39 of the atrial sealing skirt is used to at least partially retract the delivery guide 38 around the atrial sealing skirt 46 when the atrial sealing skirt 46 is in the desired deployment position 5 . In the guide 38 without the sealing skirt 46, the skirt 46 expands to its full, unconstrained size. Optionally, since the position of the atrial sealing skirt is adjustable, the deployment knob 39 of the atrial sealing skirt is used to expand the sealing skirt 46 near the desired deployment position.

Atrial positioning rod 44 is then placed over each suture 45 such that a portion of each suture 45 extends within inner rod lumen 62 and a portion of each suture extends beyond proximal end 61 of positioning rod 44 . 13A and 13B, the positioning rod 44 is then inserted through the guide 38 of the atrial sealing skirt, and a portion of the cord 21 is received by the inner rod lumen 62 of the rod 44, and the distal end 54 of the positioning rod (with a connecting Attached thereto is a removable lock 56 ) adjacent the atrial sealing skirt 46 . The user pushes the plurality of positioning rods 44 down until the sealing skirt is in a desired position relative to the tricuspid annulus.

The location of the atrial sealing skirt 46 does not require pulling the tether 18 through the ventricular apex heart 2 because the atrial sealing skirt 46 is free to move on the tether 18 until the desired skirt 46 position is reached. After the desired valve position is achieved, at least one atrial locating rod 44 pushes the atrial sealing skirt 46 into place and is secured by a removable lock nested within each body 53 and attached to the end of each locating rod 44 56 to be locked in place. The atrial sealing skirt 46 can be repositioned or retracted until the sutures 45 extending through each atrial locating rod 44 are released.

As shown in FIGS. 15A and 15B , the atrial sealing skirt 46 is positioned within the right atrium 3 such that the upper edge 47 of the atrial skirt conforms to the shape of the right atrium floor 4 . Via the delivery system end 41 of the atrial sealing skirt, the practitioner advances one or more atrial positioning rods 44 to translate the atrial sealing skirt 46 on the one or more cords 21 Extending through one or more tubes 53 defined by the atrial skirt body 48 . As shown in Figure 15B, as the atrial sealing skirt 46 is advanced to the right ventricle 6, the atrial skirt superior edge 47 contacts the atrial floor 4 and the one or more extension members 49 flex according to the local anatomy. Since each atrial positioning rod 44 is pushed by a differential force, a precise amount of tension can be obtained, and thus the extension member 49 is more or less curved to facilitate the atrial skirt upper edge 47 to conform to the entire circumference around the atrial floor 4, Instead, regurgitation is restricted through the tricuspid valve orifice.

Figure 22 shows the transition of the atrial skirt superior edge 47 from concave to convex. When the valve is pushed down to the atrial floor 4 by the atrial positioning rod 44 (FIGS. 15A and 15B) attached to the extension member base 50 of the extension member 49, the extension member tip 51 is bent upward to conform to the atrial floor anatomy. Further distal movement of the valve 100 (shown from left to right in FIG. 22 ) further changes the shape of the sealing skirt 46 as it conforms to the atrial floor and pushes down the extension member base 50 ( FIG. 13A, 15A and 15B). By way of example only, the description of positioning and adjustment of the atrial sealing skirt 46 as described above refers to positioning the atrial sealing skirt 46 on the left atrial floor 9 to limit regurgitation through the mitral valve orifice 10 .

Referring now to FIGS. 19A and 19B , pulling the retracted hypotube 58 causes the locking clip 59 to retract, which pushes the locking tab 63 downwardly into engagement with the cord 21 . More specifically, the second hypotube 58 is retracted, and due to its connection to the locking clip 59 it also retracts the locking clip 59 . The locking clip 59 contacts the contact point 64 of the first gate hypotube 57 when retracted, breaking the locking clip 59 to allow the second hypotube 58 to be removed. Once the retracted hypotube 58 is pulled, the inner arms of the gateway hypotube 57 spring inwardly, allowing the gateway hypotube to be removed. The first gate hypotube 57 is beneficial because it enables the cord 21 to be locked when the second hypotube 58 is retracted. The gateway hypotube 57 is then removed, leaving the locking clip 59 within the body 53 of the atrial sealing skirt 46 . Figure 20A shows a cross-sectional view of a fully engaged lock. According to one aspect, the locating rod 44 may be integral with the gateway hypotube or removably connected to the gateway hypotube. Figure 20B shows a full view of a fully engaged lock. It should be understood that the locking system of the applicant's US Patent No. 15/943,792 may be employed in place of the locking system described herein. The locking system may be used in any system without departing from the spirit and scope of the present invention.

With the atrial sealing skirt securely conforming to the atrial floor 4 as shown in Figures 21A and 21B, the suture cutter 65 is moved 45 over the suture and then to the upper edge 47 of the atrial skirt. Suture cutter 65 cuts and releases the distal end of each suture 45 over removable lock 56 . The suture 45 and suture cutter 65 are then removed from the heart 2 .

In one aspect, the atrial sealing skirt 46 may be retrieved or repositioned prior to cutting the sutures 45 . For example, if it is determined that the atrial sealing skirt is to be removed or repositioned, an atrial locating rod 44 is positioned over each suture so that a portion of the suture is located in the inner rod lumen 62 . When the distal end 54 of the positioning rod is adjacent to or in contact with the removable locking member 56, the cassette hypotube 57 is advanced, and the retracted hypotube 58 attaches the removable locking member to the positioning rod , thereby releasing the locking of the rope 21. With each cord unlocked, the valve can be removed from and/or repositioned in deployment position 5 .

In another aspect, the atrial sealing skirt 46 may be repositioned and/or removed days to weeks after valve placement. In this regard, the suture is not cut, but rather wrapped around a spool or other wrapping device. The device is then attached to the valve on the superior edge 47 of the atrial skirt. Several days after setting the valve and completing the procedure, the spool/winding device can be recaptured so that the sutures can be unwound and retrieved. Atrial positioning rod 44 is then positioned over each suture so that a portion of the suture is located within inner rod lumen 62 . When the distal end 54 of the positioning rod is adjacent to or in contact with the detachable locking member 56, the cassette hypotube 57 is advanced while the retracted hypotube 58 attaches the detachable locking member to the positioning rod , thereby releasing the locking of the rope 21. With each cord unlocked, the valve can be removed from and/or repositioned in deployment position 5 .

Although several aspects of the invention have been disclosed in the above specification, those skilled in the art will appreciate that many modifications and adaptations are included in this specification. Other aspects of the invention will come to mind having the benefit of the teachings presented in the foregoing specification and the associated drawings. It is therefore to be understood that the inventions are not to be limited to the specific aspects disclosed above and that many modifications and other aspects are intended to be included within the scope of the appended claims. Furthermore, although specific terms are employed herein and in the claims that follow, they are used in a generic and descriptive sense only and not for the purpose of limiting the described invention.

Claims (59)

1. A medical assembly for minimally invasive implantation of an atrial sealing skirt into a heart at a deployed position of the atrial sealing skirt, the medical assembly comprising: the medical assembly includes:

an atrial sealing skirt configured to receive a valve and for intravascular introduction and implantation at a deployed location and configured and dimensioned to replace a native heart valve, said atrial sealing skirt having a portion configured to substantially conform to an atrial floor proximate said deployed location of the valve;

an anchor assembly configured and dimensioned for intravascular introduction for implanting the anchor at an implantation site within an endocardial wall, and including a delivery cable;

a tether comprising at least one cord connected to the anchor and the atrial sealing skirt for operably connecting the atrial sealing skirt and the anchor;

a removable anchor delivery system for introducing the anchor within a vessel; and

a delivery system for a removable atrial sealing skirt for positioning and sealing the atrial sealing skirt.

2. The medical assembly of claim 1, wherein: the anchor assembly includes:

an anchor cap having a proximal end and a distal end; and

an anchor screw extending distally from said anchor cap and configured to penetrate a predetermined distance into said endocardial wall at said implantation site; and

a locking member on the anchor cap for locking the tether, the locking member selectively movable from a first locked position to a second unlocked position.

3. The medical assembly of claim 2, wherein: the at least one locking member is a locking arm extending radially outward from the anchor cap.

4. The medical assembly of claim 2, wherein: the anchor includes at least two of the locking elements.

5. The medical assembly of claim 1, wherein: the atrial sealing skirt further comprises:

an anchor cap having a proximal end and a distal end, wherein the proximal end includes a first surface configuration;

an anchor screw extending from a distal end of said anchor cap and configured to penetrate a predetermined distance into said endocardial wall at said implantation site; and is

The delivery cable includes a distal end having a second surface configuration configured to mate with the proximal surface configuration of the anchor cap.

6. The medical assembly of claim 5, wherein: the delivery cable comprises a flexible wire.

7. The medical assembly of claim 5, wherein: the first surface configuration of the anchor cap is defined by a chamber having threaded sidewalls, and the second configuration of the delivery cable distal end is an outer surface configuration that mates with and engages the anchor cap, wherein the anchor delivery cap rotates the anchor cap when rotational forces are applied thereto.

8. The medical assembly of claim 5, wherein: the tether includes: a docking ring defining a central aperture for receiving the flexible wire of the delivery cable; and

at least one tether bar is movably connected to the docking ring.

9. The medical assembly of claim 8, wherein: the anchor cap includes at least one locking member that is selectively movable from a first locked position to a second unlocked position, and the tether docking ring cooperate with the at least one locking member of the anchor cap to secure the tether to the anchor cap when the locking member is in the first position.

10. The medical assembly of claim 9, wherein the at least one tether lever is rotatably connected to the docking collar and is substantially rigid.

11. The medical assembly of claim 10, wherein a distal end of the tether bar defines a hook, and wherein the abutment ring includes an eyelet configured to receive the hook.

12. The medical assembly of claim 8, wherein said tether further comprises at least one suture extending from a proximal end of said at least one tether rod.

13. The medical assembly of claim 12, wherein said tether includes at least two said tether levers and at least two said sutures extending from a respective said tether lever.

14. The medical assembly of claim 1, wherein the anchor delivery assembly comprises:

an anchor delivery guide defining a longitudinally extending lumen and having a proximal end and a distal end; and

an anchor delivery rod defining a longitudinally extending lumen and having a proximal end and a distal end, and having a distal portion, wherein sidewalls of the delivery rod lumen have a second configuration, and wherein a proximal portion of the anchor cap includes a first configuration for mating with the second configuration of the delivery rod lumen for selective mating therewith for implanting the anchor screw to the implantation site.

15. The medical assembly of claim 14, wherein said anchor delivery assembly further includes a sheath defining a longitudinally extending lumen for receiving a portion of said anchor delivery guide, said sheath having a length less than a length defined between said proximal end and said distal end of said anchor delivery guide.

16. The medical assembly of claim 13, further comprising a guide handle for receiving a proximal portion of the anchor delivery sheath.

17. The medical assembly of claim 1, wherein: the medical assembly also includes a J-wire configured for intravascular insertion to guide the anchor delivery system.

18. The medical assembly of claim 14, wherein: the atrial sealing skirt delivery system also includes a rotation handle on a proximal end of the delivery rod for assisting in the rotation of the delivery rod to rotate the anchor.

19. The medical assembly of claim 1, wherein: the tether further includes at least one suture extending from a proximal end of the at least one cord.

20. The medical assembly of claim 1, wherein: the medical assembly further comprises: a tether delivery assembly comprising a removable tether delivery sheath defining a longitudinally extending lumen configured to receive the tether.

21. The medical assembly of claim 1, wherein: the delivery system for the atrial skirt comprises:

an atrial sealing skirt delivery guide having a proximal end and a distal end and defining an inner guide extension lumen therebetween, wherein the delivery sheath is removable and positioned along the delivery cable, and wherein the sheath includes the atrial sealing skirt operably connected to the cord extending within the sheath lumen.

22. The medical assembly of claim 21, wherein: the tether includes a docking ring defining a central aperture for receiving the flexible line of the delivery cable, and at least one tether rod movably connected to the docking ring and configured to be attached to the flexible line of the delivery cable

The delivery guide further comprises the tether within the lumen, wherein the atrial sealing skirt is connected to the tether within the lumen.

23. The medical assembly of claim 22, wherein: the atrial sealing skirt delivery system also includes an atrial sealing skirt deployment knob having a central channel for receiving a proximal portion of the atrial sealing skirt delivery guide, and wherein the atrial sealing skirt delivery guide is retractable within the atrial sealing skirt deployment knob when retracted.

24. The medical assembly of claim 23, wherein: the atrial skirt delivery system further comprises at least one positioning rod having a central lumen for insertion by the at least one cord of the tether, and wherein the at least one positioning rod has a length sufficient to extend proximally of the deployment knob and into the heart to contact the atrial sealing skirt.

25. The medical assembly of claim 1, wherein: the medical assembly further includes a locking system for locking the atrial sealing skirt on the atrial floor, and wherein the atrial skirt delivery system further includes at least one positioning rod having a central lumen for insertion by the at least one cord of the tether, the atrial sealing skirt includes an atrial superior rim, and the locking system includes at least one tube extending below the superior rim, and wherein the superior rim defines at least one aperture of the tube, and the locking system further includes a removable locking member positioned within the tube, the tube configured to engage the at least one positioning rod to lock the superior rim on the atrial floor.

26. The medical assembly of claim 25, wherein: the detachable lock defines a central lumen, and the cord of the tether is received within the lumen of the lock.

27. The medical assembly of claim 26, wherein: the locking system also includes a first gateway hypotube defining a central lumen and configured to be received by the detachable lock lumen and configured to cooperate with the detachable lock to secure the at least one tether.

28. The medical assembly of claim 1, wherein: the atrial sealing skirt defines a valve seat, and the medical assembly includes a valve within the valve seat.

29. An atrial sealing skirt configured to receive a valve and for intravascular introduction and implantation at a deployed location and configured and dimensioned to replace a native heart valve, said atrial sealing skirt configured to substantially conform to an atrial floor proximate said valve deployed location, characterized in that: the atrial sealing skirt comprises:

an atrial skirt body having a generally cylindrical shape and defining a valve seat;

an atrial skirt upper edge extending circumferentially around the atrial skirt upper edge, wherein the atrial sealing skirt is compressible when constrained and expandable when unconstrained;

at least one tube having an open upper end defined by an aperture in the skirt rim, wherein the tube extends from the aperture and below the skirt rim;

at least one extension member for supporting said skirt rim, said extension member having a base end adjacent said skirt body edge, said skirt body edge extending substantially outwardly to an outer edge of said skirt rim;

at least one body support for supporting said skirt body; and

a membrane material covering the at least one extension member and the at least one body support for forming the skirt rim and body.

30. The atrial sealing skirt of claim 29, wherein: the atrial sealing skirt defines a valve seat, and the medical assembly includes a valve within the valve seat.

31. The atrial sealing skirt of claim 29, wherein: the at least one extension member is non-linear.

32. The atrial sealing skirt of claim 29, wherein: the at least one extension member is a plurality of the extension members.

33. The atrial sealing skirt of claim 29, wherein: the at least one body support is a plurality of extension members forming a lattice structure.

34. The atrial sealing skirt of claim 29, wherein: the at least one tube is at least two tubes.

35. The atrial sealing skirt of claim 29, wherein: the at least one tube extends adjacent an outer side surface of the atrial skirt body.

36. The atrial sealing skirt of claim 29, wherein: the membrane is formed from a synthetic material.

37. The atrial sealing skirt of claim 29, wherein: the at least one tube is configured to receive a locking system for locking the atrial sealing skirt on the atrial floor.

38. The atrial sealing skirt of claim 37, wherein: the locking system includes a removable locking member positioned within the tube to lock the superior edge against the atrial floor.

39. The atrial sealing skirt of claim 38, wherein: the removable locking element defines a central lumen configured to receive a cord for securing the atrial sealing skirt.

40. The atrial sealing skirt of claim 39, wherein: the locking system also includes a first hypotube defining a central lumen and configured to be received by the detachable lock lumen and configured to mate with the detachable lock.

41. The atrial sealing skirt of claim 39, wherein: the locking system also includes a second hypotube defining a central lumen and configured to be received by the first hypotube.

42. The atrial sealing skirt of claim 29, wherein the atrial skirt upper edge is substantially concave before remaining in conformance with the atrial floor.

43. The medical assembly of claim 2, wherein: the predetermined distance of the anchor screw is a distance sufficient to penetrate and exit an endocardial wall at the implantation site.

44. The medical assembly of claim 44, wherein: the anchor assembly includes:

an anchor shaft having a distal end and a distal portion for penetrating the endocardial wall and extending from the distal end of the anchor cap, and the anchor screw extending circumferentially around the anchor shaft;

the distal end portion of the anchor shaft defines at least two anchor zones, the at least two anchor zones comprising a respective portion of the anchor screw;

a tensioning device is operably connected to the anchoring zone, wherein when the anchoring zone has penetrated and moved away from the inner wall of the heart, the tensioning device is released, thereby expanding and anchoring the anchoring assembly.

45. The medical assembly of claim 45, wherein: the tensioning device is a tensioning line extending through the anchoring shaft and the tensioning line comprises at least two distal lines for connection to a respective one of the at least two anchoring zones.

46. The medical assembly of claim 2, wherein: the anchor includes:

an anchor shaft defining a first surface configuration and the anchor screw extending distally from the anchor shaft;

wherein the at least one locking member extends from the anchor shaft between a first locked position and a second unlocked position;

a removable anchor connector and a connector link connected to the anchor connector, the anchor connector having a second surface configuration, wherein the second surface configuration and the first surface configuration of the anchor shaft are mating surfaces, wherein the anchor connector, when mated with the anchor shaft, retains the at least one locking member in the second unlocked position; and

the tether includes a tether loop configured to receive the anchor connector and anchor rod and to engage the at least one locking element to be locked in position on the anchor shaft when the anchor connector is removed, the tether loop defining a coupling device.

47. The medical assembly of claim 47, wherein: the first surface configuration of the anchor shaft includes at least one flange and a groove, and the second surface configuration of the anchor connector includes at least one mating groove and flange for coupling with the anchor shaft.

48. A method of intravascular delivery and implantation of a medical assembly for minimally invasive implantation of an atrial sealing skirt having a generally cylindrical skirt body and an atrial sealing skirt upper rim extending circumferentially about an upper rim of the skirt body at a deployment location of the ventricular sealing skirt, sealing the upper rim against respective atrial floors of the heart and anchoring the atrial sealing skirt to an endocardial wall at an implantation location, the anchor having an anchor screw, anchor cap and delivery cable, and a tether connecting the anchor and the sealing skirt, the medical assembly comprising a removable anchor delivery system having an anchor delivery guide defining a longitudinally extending lumen and having an anchor delivery rod, the anchor delivery rod defining an inner rod lumen, the anchor delivery rod removably positionable within the anchor delivery guide, a second delivery system including a second delivery guide defining an inner guide lumen configured to receive at least a portion of the tether and including at least one positioning rod, the method comprising the steps of:

removably coupling the delivery cable and the anchor cap, and removably coupling the anchor delivery rod and the anchor cap;

intravascularly passing the anchor delivery system into a heart, wherein the anchor delivery system comprises the anchor delivery guide, at least a portion of the delivery rod and at least a portion of the anchor being positioned within an inner lumen of the anchor delivery guide;

advancing a distal end of the anchor delivery guide through the deployment site to the implantation site into the heart;

advancing the anchor delivery rod and contacting the anchor screw against the implantation site;

manipulating the anchor delivery rod and implanting the anchor to the implantation location to implant the anchor into the endocardial wall;

retracting the anchor delivery rod and causing the anchor to be implanted at the implantation site, and the anchor delivery cable extending from the anchor cap, through the atrial sealing skirt deployment site, and outwardly from the heart;

guiding the second delivery system intravascularly over a delivery cable secured to the implanted anchor by introducing the second delivery guide, the second delivery guide comprising the tether having at least one cord extending from a proximal end of the tether and the cord extending intraluminally within the delivery guide;

advancing the second delivery system such that the tether is coupled with the anchor cap; and is

Locking the tether to the anchor cap.

49. The method of claim 49, further comprising, prior to said locking step, the steps of:

providing the tether and the atrial skirt within the second delivery guide lumen, and the step of guiding the second delivery system intravascularly comprises introducing the tether and atrial sealing skirt, and wherein the step of advancing the second delivery system comprises: advancing the second delivery guide through the deployment location and locking the tether to the anchor cap and positioning the atrial sealing skirt proximate the deployment location;

positioning at least one positioning rod along a proximal portion of the at least one tether outside the heart, wherein the positioning rod extends in the second delivery guide inner lumen, and the step of inserting the second delivery system intravascularly comprises guiding the positioning rod over the at least one tether;

at least partially retracting the delivery guide of the atrial sealing skirt to release the atrial sealing skirt in the deployed position and expand the atrial sealing skirt;

selectively advancing the positioning rod along the tether to contact the atrial sealing skirt upper edge to position the atrial sealing skirt;

manipulating the positioning rod to change the position of the atrial sealing skirt upper edge relative to the atrial floor and seal the atrial sealing skirt against the atrial floor, an

Further retracting the second delivery guide and retracting the positioning rod to leave the atrial sealing skirt in the deployed position and the anchor in the implanted position.

50. The method of claim 49, wherein: before the locking step, the method further comprises the following steps:

introducing a third delivery system for implanting the atrial sealing skirt and advancing the third delivery guide over the delivery cable to the deployed position;

positioning at least one positioning rod along a proximal portion of the at least one tether outside the heart, wherein the positioning rod extends within the delivery guide inner lumen, and the step of inserting the second delivery system intravascularly comprises guiding the positioning rod over the at least one tether;

at least partially retracting the delivery guide of the atrial sealing skirt to release the atrial sealing skirt in the deployed position and expand the atrial sealing skirt;

advancing the positioning rod along the tether to contact the atrial sealing skirt to position the atrial sealing skirt;

manipulating the positioning rod to change the position of the atrial sealing skirt relative to the atrial floor and seal the atrial sealing skirt upper edge against the atrial floor, an

Further retracting the second delivery guide and retracting the positioning rod to leave the atrial sealing skirt in the deployed position and the anchor in the implanted position.

51. The method of claim 49, wherein: the method further comprises the steps of: introducing a J-wire intravascularly through the deployment site into the heart to the implantation site prior to the step of coupling the delivery cable to the anchor cap, and

the step of introducing the anchor delivery system into the heart includes advancing the anchor delivery guide over the inserted J-wire for guidance.

52. The method of claim 50, wherein: the step of manipulating the anchor delivery rod and implanting the anchor to the implantation site to implant the anchor includes the step of rotating the anchor delivery rod and the anchor screw to implant the anchor screw at the implantation site.

53. The method of claim 50, wherein: the step of introducing the second delivery system further comprises providing a deployment knob for receiving a proximal portion of the second delivery guide, wherein the deployment knob is in fluid communication with the second delivery guide lumen, and the step of at least partially retracting the second delivery guide comprises retracting the second delivery guide within the deployment knob.

54. The method of claim 49, wherein: the step of implanting the anchor comprises ventricular implantation.

55. The method of claim 49, wherein: the step of implanting an anchor comprises epicardial implantation.

56. The method of claim 49, wherein: after the step of manipulating the positioning stem to seal the sealing skirt against the atrial floor, the method further comprises the steps of: locking the cable relative to the sealing skirt by providing a locking element cooperating with a distal end of the positioning rod

57. The method of claim 49, wherein: the method also includes the step of removing the second delivery system and the delivery cable.

58. The method of claim 49, wherein: the step of introducing the anchor delivery step includes introducing a suture extending from a proximal end of the at least one cord.

59. The method of claim 49, wherein: after the step of locking the cord relative to the atrial sealing skirt, the method further comprises the step of cutting at least one suture.

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